A Notice to Stakeholders was released regarding the EU-Turkey Customs Union Agreement for medical devices. The gist of the document is that the same recognition under the Medical Device Regulation old Directives , also applies under the (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) . Specifically, it confirms the following under the MDR/IVDR:
- Confirms that European Economic Area manufacturers do not need an authorized representative to place devices onto the Turkish market, and vice versa.
- EU manufacturers must appoint an European Authorized Representative (EU AR). That EU AR can be located in the EEA or Turkey.